Anna Paula Alves Oliveira Email & Phone Number

Barueri, São Paulo, Brazil

Barueri, São Paulo, Brazil

Responsible for Supplier Qualification activities for projects (registration and post-registration) of manufacturers/suppliers of inputs (APIs, excipients and packaging material); productive third parties and service providers, serving the following segments: medication, cosmetics, food and related products, from the units of the Hypera group (Brainfarma and Cosmed).

Guarulhos, São Paulo, Brazil

Responsible for Supplier Qualification activities of productive third-parties, service providers and input suppliers/manufactures (APIs, excipients and packaging material) for medicines, cosmetics, food and related products, from Aché Laboratórios manufacturing units; - Quality Agreement Management in the company: analyzing and negotiating agreements with partners and suppliers/manufacturers, of different degrees of complexities (full service, outsourcing, licensing, clones, supply and provision of services), national and international; - Conduct quality audits and monitor CAPAs in productive third-parties (medicines, food and cosmetics), service providers (laboratories, shipping company, among others) and input manufacturers; - Participate in a multidisciplinary committee for evaluation and approval of Change Controls for projects after registration of medicines, foods and cosmetics, and monitor/perform the necessary actions for the implementation of approved changes, related to Supplier Qualification; - Monitor and support national and international quality and regulatory audits and customer quality audits; - Monitor and provide support to international productive third parties and API manufacturers (new API regulatory legislation) in GMP certifications; - Perform Internal Audit and monitor CAPA in manufacturing units, DC, Quality System and corporate activities of Aché Laboratórios; - Perform monitoring of productive third-parties, service providers and suppliers/manufacturers of inputs through periodic document evaluation and Risk Analysis; - Participate in multidisciplinary forums for prospecting and evaluating new API manufacturers; - Develop procedures (SOP) for the area and/or those who include Supplier Qualification.

Suzano, São Paulo, Brazil

Responsible for activities related to Market Complaints on Suzano's site (solids, liquids, semi-solids, hormones, injectables). - Evaluate technical complaints and samples received from customers; - Evaluate retention samples and investigate, in factory, complaints investigate through quality tools, mainly Ishikawa Diagram; - Develop CAPA and monitor implementation actions; - Prepare PTC (Product Technical Complaint) report with root cause and action plan.

Suzano, São Paulo, Brazil

Responsible for Quality Management of the solids area (manufacturing and packaging): - Conduct and monitor investigations and CAPAs of quality deviations; - Manage the area's change control and monitor the actions for implementation; - Monitor Market Complaint investigations; - Monitor and support regulatory and quality audits (national and international) and customer quality audits; Participation in continuous improvement projects focused on quality, yield and performance: - Solve problems in the production process through the use of Six Sigma, 5W2H and pharmacotechnics; - Develop and apply training (Technical Operational Training - Standard Work) in manufacturing lines; - Management of Quality, Safety and Productivity and Solids Production Performance Indicators (KPI's follow-up).

Bachelor Of Engineering

Lean Six-Sigma - Black Belt

Ifa – P&D E Produção De Insumos Farmacêuticos Ativos

Capacitação De Auditores

Aplicação Dos Valores De Pde Na Validação De Limpeza

Avaliação Toxicológica: Abordagem Em Pde

Project Management: Project Management Body Of Knowledge (Pmbok) And Agile Project Management

Pharmaceutical Audit: Methodology And Practice

Advanced Level In English

Gps (Gemba Problem Solve): Focus On Problem Solving

Cga (Autonomous Management Cycle): Focus On Autonomous Maintenance, Tpm Pillar

Lean Academy I - Concepts And Tools For Lean Production

Fit4Chc – Mckinsey & Company Methodology: Focus On Productivity And Coaching & Feedback